hair loss Key 8 facts GUR701 has got Clinical Proof of Concept Results are amazing GUR701 is based on 3 new patented firstinclass molecules discovered by Gurus We have registered GUR701 in Eastern Europe as a functional cosmetic product for hair loss trademark Regeus Now we are r ID: 1034260
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1. GUR-701(Regeus®)Potential blockbuster drug for hair loss
2. Key 8 factsGUR-701 has got Clinical Proof of Concept. Results are amazing.GUR-701 is based on 3 new patented first-in-class molecules, discovered by GurusWe have registered GUR-701 in Eastern Europe as a functional cosmetic product for hair loss (trademark Regeus®). Now we are raising money to register it as a drug.Gurus BioPharm LLC has been working since 2011 in Eastern Europe. Now we have registered Gurus BioPharn Inc. in USA as a headquarters and Gurus BioPharn LLC becomes a subsidiary.We have no investors so far (there are no biotech investors in our country). The Founders have been investing their own money and grants for 10 years.The team is making permanents clinical trials for Alopecia in Eastern Europe, sponsored by Gurus. Results are amazing. The statistics is growing.Gurus CEO is an entrepreneur with 30 years of experience. COO has 10 years of entrepreneurial experience.We created the unique R&D Platform and efficient product without investor. With investor we can reach sufficiently more.
3. Why we haveClinical Proof of Concept3We have registered GUR-701 in Eastern Europe as a cosmetic product (trademark Regeus®).It made possible to fulfill clinical trials by Gurus team in Eastern Europe and to sponsor them by Gurus revenue without investor.Clinical trials show amazing results. Keep refrigeratedTopical application 1 time per day$99for 3-months supply
4. Clinical trials results4No adverse effects (clinical data in 3 000 patients)Hair count increases by 20%-30% in 6 months (clinical data in 100 patients)Thinned hair become thick again in 3 monthsGUR-701 stops hair loss caused by COVID-19 and restores hair within 0.5-1.5 months80% of patients respond to GUR-701 and achieve the effectGUR-701 is effective both for men and women
5. GUR-701 (Regeus®) is much more efficient and safer than gold standard (Minoxidil)Key Advantages Efficacy Gold standard (Minoxidil)GUR-701The amount of thinned hair restored to its normal diameter in 3 months0%85%Increase in the amount of hair in 6 months11%25%Side effectsMinoxidil GUR-701if you stop using Minoxidil, your hair will fall out quickly to pre-therapy stateafter 1 year of using Minoxidil, the results achieved begin to declinehair growth in ears, on the face, shouldersdermatitisNo side effects Response rateMinoxidil GUR-70130%80%the percentage of patients on whom a therapy has an effect
6. Unmet medical need6There is no effective drug for alopecia (hair loss).15% of world population are suffering from the hair loss.*Source: American Hair Loss Association (AHLA)
7. Results in men7Man, 35 years. MPHL, androgenetic alopecia, Hamilton-Norwood grade III. Hair count increased by 52% in 4 monthshair under60 times magnificationBeforeAfter
8. 8100 patients participated in efficacy study. The study continues, statistics is growing BeforeAfterResults in womenWoman, 28 years old. Diagnosis: FPHL, androgenetic alopecia, Ludwig grade II. The result of using GUR-701 within 4 months.
9. Better than “gold standard”9Minoxidil is currently a “gold standard” in hair loss treatment.For 6 months, GUR-701 increases the amount of hair on the head by 25% and Minoxidil by only 9%-11%.Source: GUR-701 clinical trials in Eastern Europe, 2019-2021Minoxidil clinical trials by Johnson & Johnson https://clinicaltrials.gov/ct2/show/results/NCT01145625?term=minoxidil&cond=AGA&draw=4
10. Increase in hair diameter10After 3 months of using GUR-701 thinned hair becomes thick again. GUR-701 increases thinned hair diameter up to 30% to normal hair diameter.No one drug can do so (no clinical data).An increase in hair diameter by 20% increases hair volume as much as by 40% (hair volume = ¼πd² * L)Increasing the hair diameter to normal means that the weakened follicle is healthy again.Source: GUR-701 clinical trials in Eastern Europe, 2019-2021
11. Active ingredientsActive ingredients (API) are 3 patented first-in-class molecules, currently registered in INCI: - Nitroproston® = prostaglandin E2 + Nitric Oxide donor (INCI name-Dinitroglyceryl Dinoprostonate) - Prostanit® = prostaglandin E1 + Nitric Oxide donor, (INCI name- Dinitroglyceryl Alprostadilate) - Serinoprost® = prostaglandin F2 + amino acid Serine (INCI name- Dinoprostoyl IsopropylserinateOur modified prostaglandins are significantly superior in activity to natural prostaglandins, that leads to the target effect at lower doses.
12. Mechanism of action121) Modified prostaglandin E2 activates dermal papilla stem cells through WNT pathway, which create new hair. 2) Modified prostaglandin E1 restores the narrowed diameter of arterioles and capillaries to normal thus restoring blood supply and feeding of follicles.3) Modified prostaglandin F2alfa increases hair growth period (anagen) from initially short to normal one.
13. Patents13PCT claim was submitted for the following countriesNational Phase is in Dec 2021 Australia (AU)Benelux (BX)Canada (CA)Switzerland (CH)China (CN)Czech Republic (the) (CZ)Germany (DE)Denmark (DK)Estonia (EE)Spain (ES)Finland (FI)France (FR)United Kingdom (the) (GB)Ireland (IE)Israel (IL)India (IN)Iran (Islamic Republic of) (IR)Italy (IT)Japan (JP)Republic of Korea (the) (KR)Norway (NO)New Zealand (NZ)Russia (RU)Sweden (SE)Singapore (SG)Turkey (TR)United States of America (the) (US)
14. Trademark registration14Armenia (AM)Austria (AT)Australia (AU)Azerbaijan (AZ)Bosnia and Herzegovina (BA)Bulgaria (BG)Benelux Office for Intellectual Property (BX)Belarus (BY)Canada (CA)Switzerland (CH)China (CN)Colombia (CO)Cyprus (CY)Czech Republic (the) (CZ)Germany (DE)Denmark (DK)Algeria (DZ)Estonia (EE)Egypt (EG)Spain (ES)Finland (FI)France (FR)United Kingdom (the) (GB)Greece (GR)Croatia (HR)Hungary (HU)Indonesia (ID)Ireland (IE)Israel (IL)India (IN)Iran (Islamic Republic of) (IR)Italy (IT)Japan (JP)Kyrgyzstan (KG)Republic of Korea (the) (KR)Kazakhstan (KZ)Lithuania (LT)Latvia (LV)Mexico (MX)Malaysia (MY)Norway (NO)New Zealand (NZ)Philippines (PH)Poland (PL)Portugal (PT)Russia (RU)Romania (RO)Serbia (RS)Sweden (SE)Singapore (SG)Slovenia (SI)Slovakia (SK)Thailand (TH)Turkey (TR)Ukraine (UA)United States of America (the) (US)Uzbekistan (UZ)Viet Nam (VN)Trademark Regeus ® is registered in 58 countriesClasses: 03 (cosmetics) and 05 (pharma)
15. Consumers15Segment 1: Women 25-55 years, diffuse or androgenetic alopecia, 1-2 stage of Ludwig scale(initial and moderate stage)Segment 2: Men 20-55 years, androgenetic alopecia, 1-4 stage of Hamilton-Norwood scale(initial and moderate stage)
16. Hair loss treatment drugs16There are only 2 FDA approved drugs for hair loss treatment. Minoxidil (gold standard for hair los treatment)Finasteride and Dutasteride (which are 5-alpha-reductase inhibitors).Minoxidil$59for 3 months supplyGUR-701 (Regeus)$99for 3 months supplyEffect after 6 months11% increase in hair count30% Response rate Effect after 6 monthsdecreases hair loss for menFinasteride is not efficient for womenEffect after 6 months25% increase in hair count80% Response rate Finasteride$120for 3 months supply
17. Hair treatment medical procedures17The most effective hair treatment medical procedures arePRP therapy (platelet-rich plasma injection in scalp)Hair transplantPRP therapy$300Hair transplant$4,000 - $15,000 (US)$2,000 - $5,000 (Eastern Europe) Effect after 6 months:15% increase in hair countNo hair count increase**Hair transplant removes hair follicles from the back of the head, to a bald part of the head. Some transplanted follicles will die.GUR-701 (Regeus)$99for 3 months supplyEffect after 6 months25% increase in hair count
18. Adverse effects18GUR-701 (Regeus)No adverse effects(statistics based on 3,000 patientsfor the period 2019-2021)Minoxidilif you stop using Minoxidil, your hair will fall out quickly to pre-therapy stateMinoxidil launches hair growth on undesirable places (in ears, on the face in women, on the shoulders, etc.)It causes dermatitisFinasterideFinasteride causes impotence in menFinasteride is not effective for women
19. Adverse effects19PRP therapyPainful invasive procedureYou can not use PRP for hair support on monthly basisHair transplantPainful invasive procedure2-3 month long postoperative hair restoration period*. The transplant does not increase the total hair count***Within 1 month after surgery, the transplanted hair will fall out. 1-2 more months requires to regrow new hair of 1-2 cm long**Hair is removed from the donor region and transplanted to the bald place. some transplanted follicles will dieGUR-701 (Regeus)No adverse effects(statistics based on 3,000 patientsfor the period 2019-2021)
20. Cost and Price Keep refrigerated$99for 3-months supply
21. Market21Market 2027 = $13 billionCAGR = 5.5%.Patients15% of global population suffer from hair loss150 million people is total market (15% of Golden Billion population)Key segmentsDrugs (Minoxidil, Finasteride)Medical procedures (PRP, mesotherapy)Surgery (hair transplant)Equipment (helmets, laser combs)Source: Inkwood researchGlobal Alopecia (Hair Loss) Treatment Market forecast 2019-2027
22. Unicorn potential22Forecast 2027Market = $13 billionRegeus market share = 10%Regeus sales = $1.3B
23. Low R&D risks23GUR-701 has low R&D risksWhy low risks?Preclinical and clinical studies has been done already in Eastern EuropeNow we need just to repeat some of these studies in compliance with GLP / GCP The product based on GUR-701 is registered as a functional cosmetic product (Regeus). 3 000 people are using RegeusSafety is proved on 3 000 patentsEfficacy is proved on 100+ patients
24. InvestmentWe are raising $8M in Series A to expand the Active Pharmaceutical Ingredients output (CMC) and repeat preclinical studies in the USA which have been previously made in Eastern Europe. Total R&D cost is $17M (3 years). Expected result is regulatory approval.
25. Founders25Prof. Vladimir Bezuglov, D.Sc.Chief Scientific Officer,Founder, DirectorInventor and pioneer in prostaglandins modification by Nitric Oxide donor. Synthesis of active pharmaceutical and cosmetic ingredientsTechnology developmentPatentingIgor Serkov, D.Sc.Chief Technology Officer,Founder, DirectorInventor and pioneer in prostaglandins modification by Nitric Oxide donor. Synthesis of active pharmaceutical and cosmetic ingredientsTechnology developmentIgor Lyubimov, Ph.D.Chief Operating Officer,Founder, DirectorBusiness Development Product developmentPreclinical and clinical trialsPatentingRegulatory affairsManufacturingChemical purchasesMedical issuesIgor Teterin, DBA, MBACEO, Founder, DirectorBusiness Development SalesMarketingPRManagementHRFinanceLegal issues
26. Team26ContactGurus BioPharm LLC.Igor Lyubimov, CEO, Founderlyubimov@gurus.biowww.gurus.bio